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Boston Scientific gains WallFlex esophageal stent clearance

This article was originally published in The Gray Sheet

Executive Summary

Firm gains 510(k) clearance and CE-mark approval for its WallFlex fully covered esophageal stent, designed to treat malignant esophageal obstructions caused by tumors in patients with esophageal cancer, the firm announces Nov. 20. A partially covered version of the self-expanding esophageal stent debuted in 2008. The devices employ a proprietary Permalume silicone covering to prevent tumor ingrowth, seal concurrent esophageal strictures and help reduce food impaction, the company explains

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